正交试验优化天山雪莲骨架缓释片处方

Optimum of Saussurea involucrate Gel Sustained-release Matrix Tablets by Orthogonal Design

目的:优化天山雪莲缓释片制备工艺并探讨药物释药机制。方法:采用正交实验法,以绿原酸、芦丁累积释放度综合评分K值为指标,优选HPMC用量、淀粉:乳糖的比例和微晶纤维素用量,采用数学模型拟合释放曲线。结果:最佳处方为HPMC K15M用量为17%,淀粉:乳糖为2∶1,MCC用量为1%;优化后的处方释放模型符合Higuchi方程。结论:天山雪莲缓释片体外释放性能良好,为处方设计合理性提供了依据。

Objective：To optimize the Saussurea involucrate sustained-release tablets and to study the release mechanism of the mainactive composition of Saussurea involucrate.Method：The amount of HPMC and MCC,the ratio of starch with lactose were screened by using method of orthogonal design and by selecting cumulative release of chlorogenic acid and rutin as index.Mathematic models were used to imitate the drug release.Result：The optimum formula was as follows the amount of HPMC K15m was 17%,the ratio of starch with lactose was 2∶ 1 and the amount of MCC was 1%.The release of chlorogenic acid and rutin was conformed to Higuchi equation.Conclusion：The release of two mainactive composition of Saussurea involucrate could be well described in vitro and give good foundation for rationality of formula design.